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Sponsors and Collaborators: |
M.D. Anderson Cancer Center Eisai Medical Research Inc. |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00410488 |
Objectives:
Condition | Intervention |
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Sarcoma Nausea Vomiting |
Drug: Palonosetron |
Study Type: | Interventional |
Study Design: | Supportive Care, Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Dose/Schedule Finding Study of Palonosetron in Sarcoma Patients Receiving Multi-Day Chemotherapy With Adriamycin and Ifosfamide (AI) |
Estimated Enrollment: | 50 |
Study Start Date: | December 2006 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Palonosetron X 1 Dose
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Drug: Palonosetron
Arm 1: Palonosetron 0.25 mg IV x 1 dose (day 0). Arm 2: Palonosetron 0.25 mg IV x 3 doses (days 0, 2, 4).
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2: Experimental
Palonosetron X 3 Doses
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Drug: Palonosetron
Arm 1: Palonosetron 0.25 mg IV x 1 dose (day 0). Arm 2: Palonosetron 0.25 mg IV x 3 doses (days 0, 2, 4).
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Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Pamela Walker, RN | 713-745-2767 |
United States, Texas | |
The University of Texas M.D.Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Principal Investigator: Saroj Vadhan-Raj, MD |
Principal Investigator: | Saroj Vadhan-Raj, MD | M.D. Anderson Cancer Center |
Responsible Party: | U.T.M.D. Anderson Cancer Center ( Saroj Vadhan-Raj, MD/Professor ) |
Study ID Numbers: | 2005-0664 |
Study First Received: | December 11, 2006 |
Last Updated: | December 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00410488 |
Health Authority: | United States: Institutional Review Board |
Sarcoma Palonosetron Aloxi Nausea Vomiting |
Vomiting Signs and Symptoms, Digestive Malignant mesenchymal tumor Soft tissue sarcomas Doxorubicin Serotonin Signs and Symptoms |
Neoplasms, Connective and Soft Tissue Ifosfamide Palonosetron Sarcoma Nausea Isophosphamide mustard |
Neurotransmitter Agents Serotonin Antagonists Neoplasms Serotonin Agents |
Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Pharmacologic Actions |